FDA UDI
Not in Commercial Distribution
🇺🇸 United States
INSORB
DI: 00867516000111
·
Model: 1008
·
Coopersurgical, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- INSORB
- Primary DI
- 00867516000111
- Version / Model
- 1008
- Catalog Number
- REF1008
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 9
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- f38b0375-d582-4d35-8334-14b26da7655d
- Distribution End Date
- 2022-05-18
Device Description
INSORB Subcuticular Skin Stapler REF1008 (each)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GAG | Stapler, Surgical | General Hospital | 878.4740 | 2 |
| GDW | Staple, Implantable | General, Plastic Surgery | 878.4750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34606 | Skin stapler/staple, bioabsorbable | A hand-held manual surgical instrument, preloaded with bioabsorbable skin staples, designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of material(s) that are gradually degraded and absorbed by the body (typically biodegradable polymer). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00867516000111 | GS1 | ||||
| Package | 10867516000118 | GS1 | Carton | 12 | Not in Commercial Distribution | 2022-05-18 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid prolonged exposure to elevated temperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 61 – 77 Degrees Fahrenheit