FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 00304040029091
·
Model: 9009734
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 00304040029091
- Version / Model
- 9009734
- Catalog Number
- 9009734
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 1
- Public Version Date
- 2018-10-25
- Public Version Status
- New
- Public Device Record Key
- 66c39b07-bf48-4d80-851e-2303966c4843
Device Description
Stapler Skin Disposable 35R
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
- Yes
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAG | STAPLER, SURGICAL | General Hospital | 878.4740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46332 | Skin stapler | A sterile hand-held surgical instrument designed for the application of skin staples to approximate free edges of skin from an incision or wound. This device, often pistol-like in design, is typically loaded with staples and is intended to mechanically deliver staples with manual power. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10304040029098 | GS1 | Dispenser box | 5 | In Commercial Distribution | |
| Primary | 00304040029091 | GS1 | ||||
| Package | 20304040029095 | GS1 | case | 20 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 5.9 | Millimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 50 – 80 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- with no erosive gas