PRESSFT NP261
GUDID 20845854036638
PRESSFT 2.6 W/ONE NO. 2 (5 METRIC) HI-FI SUTURE (1 WHITE/BLACK)
Conmed Corporation
Tendon/ligament bone anchor, non-bioabsorbable| Primary Device ID | 20845854036638 |
| NIH Device Record Key | 2920d93f-98f1-479c-add3-1e449b468736 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PRESSFT |
| Version Model Number | NP261 |
| Catalog Number | NP261 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| 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
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10845854036631 [Package] Package: Carton [1 Units] In Commercial Distribution |
| GS1 | 20845854036638 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K112965
FDA Product Code
| MBI | FASTENER, FIXATION, NONDEGRADABLE, 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 | 5 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2015-10-24 |
On-Brand Devices [PRESSFT]
| 20845854036652 | PRESSFT 2.6 W/TWO NO. 1 (4 METRIC) HI-FI SUTURES (1 WHITE/GREEN AND 1 WHITE/BLACK) |
| 20845854036645 | PRESSFT 2.6 W/ ONE NO. 2 (5 METRIC) HI-FI SUTURE, HIP (1 WHITE/BLACK) |
| 20845854036638 | PRESSFT 2.6 W/ONE NO. 2 (5 METRIC) HI-FI SUTURE (1 WHITE/BLACK) |
| 20845854036621 | PRESSFT 2.1 W/TWO NO. 0 (3.5 METRIC) HI-FI SUTURES (1 WHITE/BLACK AND 1 WHITE/BLUE) |
| 20845854036614 | PRESSFT 2.1 W/ ONE NO. 2 (5 METRIC) HI-FI SUTURE, HIP (1 WHITE/BLACK) |
| 20845854036607 | PRESSFT 2.1 W/ONE NO. 2 (5 METRIC) HI-FI SUTURE (1 WHITE/BLACK) |
| 10845854901922 | PressFT™ Drill Guide Spike Tip, Hip |
| 10845854901892 | PressFT™ Drill Guide Crown Tip, Hip |
| 10845854027967 | PressFT™ Drill Guide, Hip |
| 10845854027912 | PressFT™ Cannulated Obturator, Hip |
| 20845854600075 | PressFT™ Flex Drill Bit 2.6 mm, Hip |
| 20845854600068 | PressFT™ Flex Drill Bit 2.1 mm, Hip |
| 20845854051167 | PressFT™ Flex 2.6 GENESYS, Hip |
| 20845854051150 | PressFT™ Flex 2.1 PEEK, Hip |
| 20845854051143 | PressFT™ Flex 2.1 GENESYS, Hip |
| 20845854051136 | PressFT™ Flex 2.6 PEEK, Hip |
| 10845854051191 | PressFT™ Flex Obturator, Hip |
| 10845854051184 | PressFT™ Flex Curved Drill Guide, Hip |
| 10845854051177 | PressFT™ Flex Straight Drill Guide, Hip |
| 10845854901915 | PressFT™ Drill Bit 2.6mm, Hip |
| 10845854901908 | PressFT™ Drill Bit 2.1mm, Hip |
| 30845854082359 | PressFT™ Drill Bit 2.1mm, Hip |
| 30845854082342 | PressFT™ Drill Bit 2.6mm, Hip |
| 30845854082335 | PressFT™ Drill Guide Spike Tip, Hip |
| 30845854082311 | PressFT™ Drill Guide Crown Tip, Hip |
| 10845854901939 | PressFT™ Cannulated Obturator, Hip |
| 10845854027950 | PRESSFT DRILL BIT, 2.6MM, HIP |
| 10845854027943 | PRESSFT DRILL BIT, 2.6MM |
| 10845854027936 | PRESSFT DRILL BIT, 2.1MM, HIP |
| 10845854027929 | PRESSFT DRILL BIT, 2.1MM |
Trademark Results [PRESSFT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRESSFT 88690079 not registered Live/Pending |
Conmed Corporation 2019-11-12 |
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