AcuJect Flex AJ FLEX 23 230 10
GUDID 10816207021253
Endoscopic injection needle
ENDO-THERAPEUTICS, INC.
General-purpose endoscopic needle, single-use| Primary Device ID | 10816207021253 |
| NIH Device Record Key | f2eb5ef0-c552-4714-a9a6-806f5fceeadc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AcuJect Flex |
| Version Model Number | AJ FLEX 23 230 10 |
| Catalog Number | AJ FLEX 23 230 10 |
| Company DUNS | 825239189 |
| Company Name | ENDO-THERAPEUTICS, INC. |
| 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 | 844-400-3636 |
| customerservice@endotherapeutics.com | |
| Phone | 844-400-3636 |
| customerservice@endotherapeutics.com | |
| Phone | 844-400-3636 |
| customerservice@endotherapeutics.com | |
| Phone | 844-400-3636 |
| customerservice@endotherapeutics.com | |
| Phone | 844-400-3636 |
| customerservice@endotherapeutics.com | |
| Phone | 844-400-3636 |
| customerservice@endotherapeutics.com | |
| Phone | 844-400-3636 |
| customerservice@endotherapeutics.com | |
| Phone | 844-400-3636 |
| customerservice@endotherapeutics.com | |
| Phone | 844-400-3636 |
| customerservice@endotherapeutics.com | |
| Phone | 844-400-3636 |
| customerservice@endotherapeutics.com | |
| Phone | 844-400-3636 |
| customerservice@endotherapeutics.com | |
| Phone | 844-400-3636 |
| customerservice@endotherapeutics.com | |
| Phone | 844-400-3636 |
| customerservice@endotherapeutics.com | |
| Phone | 844-400-3636 |
| customerservice@endotherapeutics.com | |
| Phone | 844-400-3636 |
| customerservice@endotherapeutics.com | |
| Phone | 844-400-3636 |
| customerservice@endotherapeutics.com | |
| Phone | 844-400-3636 |
| customerservice@endotherapeutics.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 2.5 Millimeter |
| Length | 230 Centimeter |
| Needle Gauge | 23 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 2.5 Millimeter |
| Length | 230 Centimeter |
| Needle Gauge | 23 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 2.5 Millimeter |
| Length | 230 Centimeter |
| Needle Gauge | 23 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 2.5 Millimeter |
| Length | 230 Centimeter |
| Needle Gauge | 23 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 2.5 Millimeter |
| Length | 230 Centimeter |
| Needle Gauge | 23 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 2.5 Millimeter |
| Length | 230 Centimeter |
| Needle Gauge | 23 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 2.5 Millimeter |
| Length | 230 Centimeter |
| Needle Gauge | 23 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 2.5 Millimeter |
| Length | 230 Centimeter |
| Needle Gauge | 23 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 2.5 Millimeter |
| Length | 230 Centimeter |
| Needle Gauge | 23 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 2.5 Millimeter |
| Length | 230 Centimeter |
| Needle Gauge | 23 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 2.5 Millimeter |
| Length | 230 Centimeter |
| Needle Gauge | 23 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 2.5 Millimeter |
| Length | 230 Centimeter |
| Needle Gauge | 23 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 2.5 Millimeter |
| Length | 230 Centimeter |
| Needle Gauge | 23 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 2.5 Millimeter |
| Length | 230 Centimeter |
| Needle Gauge | 23 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 2.5 Millimeter |
| Length | 230 Centimeter |
| Needle Gauge | 23 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 2.5 Millimeter |
| Length | 230 Centimeter |
| Needle Gauge | 23 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 2.5 Millimeter |
| Length | 230 Centimeter |
| Needle Gauge | 23 Gauge |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816207021256 [Primary] |
| GS1 | 10816207021253 [Package] Contains: 00816207021256 Package: Box [10 Units] In Commercial Distribution |
FDA Product Code
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-19 |
| Device Publish Date | 2023-07-11 |
On-Brand Devices [AcuJect Flex]
| 10816207021215 | Endoscopic injection needle |
| 10816207021253 | Endoscopic injection needle |
Trademark Results [AcuJect Flex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACUJECT FLEX 88805950 not registered Live/Pending |
Cook Medical Technologies LLC 2020-02-21 |
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