PANALOK 210625
GUDID 10886705000982
PANALOK Absorbable Anchor 3.5mm Size 1 (4 metric) PDS II (polydioxanone) suture, 36 Inches (91cm), double-armed with CP-2 needles, with disposable inserter.
DEPUY MITEK, LLC
Tendon/ligament bone anchor, bioabsorbable| Primary Device ID | 10886705000982 |
| NIH Device Record Key | 0d75e9db-7532-4e1b-ad4f-f8f489505b2b |
| Commercial Distribution Discontinuation | 2021-01-28 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PANALOK |
| Version Model Number | 210625 |
| Catalog Number | 210625 |
| Company DUNS | 190572854 |
| Company Name | DEPUY MITEK, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10886705000982 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K952687
FDA Product Code
| MAI | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2021-01-07 |
| Device Publish Date | 2015-09-01 |
On-Brand Devices [PANALOK]
| 10886705000982 | PANALOK Absorbable Anchor 3.5mm Size 1 (4 metric) PDS II (polydioxanone) suture, 36 Inches (91cm |
| 10886705002597 | PANALOK Slotted Drill Guide Sawtooth |
| 10886705002580 | PANALOK Slotted Drill Guide Fishmouth |
| 10886705001439 | ARTHROSCOPIC PANALOK RC DRILL BIT 3.2mm x 25mm |
| 10886705001422 | PANALOK RC Drill Bit 3.2mm x 25mm |
| 10886705001415 | PANALOK Drill Bit-Spade Tip 3.5mm x 18mm |
| 10886705001408 | PANALOK Drill Bit 3.5mm |
Trademark Results [PANALOK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PANALOK 74694705 not registered Dead/Abandoned |
MATSUSHITA ELECTRIC CORPORATION OF AMERICA 1995-06-28 |
 PANALOK 74599334 2153986 Live/Registered |
JOHNSON & JOHNSON 1994-11-14 |
 PANALOK 72279501 0853498 Dead/Expired |
SOUTHEASTERN TOOL AND DIE CO., INC. 1967-08-31 |
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