FDA UDI
In Commercial Distribution
🇺🇸 United States
Staple Removal Kit
DI: 00616784452227
·
Model: 4522
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Staple Removal Kit
- Primary DI
- 00616784452227
- Version / Model
- 4522
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-21
- Public Version
- 4
- Public Version Date
- 2026-04-23
- Public Version Status
- Update
- Public Device Record Key
- 413861e0-2f71-4401-a166-9793230811c2
Device Description
Staple Removal Kit with Gauze Sponge
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MCZ | Suture Removal Kit | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47192 | Skin staple remover, single-use | A hand-held manual surgical instrument intended to be used to remove skin staples after the healing process has progressed sufficiently to permit the borders of the wound or incision to remain together without assistance. It is a tweezers-like device made of metallic or synthetic polymer materials with blades at the distal end activated by lever action designed for grasping, opening, and removing surgical staples. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00616784452234 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 00616784452227 | GS1 |