DEVICE: E-PACK (10705031016316)
Device Identifier (DI) Information
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| Yes | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 33961 | General surgical procedure kit, non-medicated, single-use |
A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| FZP | CLIP, IMPLANTABLE |
| GAN | SUTURE, ABSORBABLE, SYNTHETIC |
| LDF | ELECTRODE, PACEMAKER, TEMPORARY |
| GAW | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE |
| GAQ | Suture, nonabsorbable, steel, monofilament and multifilament, sterile |
| FTL | Mesh, surgical, polymeric |
| GAM | SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: less than 25 Degrees Celsius |
| Storage Environment Temperature: less than 77 Degrees Fahrenheit |
| Special Storage Condition, Specify: Away from moisture and direct heat |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
5f78c7cd-2fc5-405a-b225-9309c9b2bdb7
June 17, 2022
6
September 24, 2015
June 17, 2022
6
September 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)384-4266
xxx@xxx.xxx
xxx@xxx.xxx