FDA UDI
In Commercial Distribution
🇺🇸 United States
Instrapac
DI: 05010058079069
·
Model: 7906
·
ROBINSON HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Instrapac
- Primary DI
- 05010058079069
- Version / Model
- 7906
- Catalog Number
- 7906
- Company Name
- ROBINSON HEALTHCARE LIMITED
- Labeler DUNS
- 237799775
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-23
- Public Version
- 2
- Public Version Date
- 2026-02-12
- Public Version Status
- Update
- Public Device Record Key
- 7b7b514a-b8fe-422c-9838-4d825a3903ac
Device Description
Instrapac Scalpel Handle BP No.3 X 50
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDZ | Handle, Scalpel | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63270 | Scalpel handle, single-use | A sterile device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05010058179066 | GS1 | Box | 50 | In Commercial Distribution | |
| Primary | 05010058079069 | GS1 |
Customer Contacts
- Phone
- +441909735502
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry and keep out of direct sunlight