FDA UDI
In Commercial Distribution
🇺🇸 United States
Instrapac
DI: 05010058088573
·
Model: 8857
·
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
- 05010058088573
- Version / Model
- 8857
- Catalog Number
- 8857
- Company Name
- ROBINSON HEALTHCARE LIMITED
- Labeler DUNS
- 237799775
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-12
- Public Version
- 2
- Public Version Date
- 2026-02-12
- Public Version Status
- Update
- Public Device Record Key
- 680a14d5-a5d8-4f29-ae17-3fbb3dc0d7db
Device Description
Instrapac Mayo Scissors Straight 17cm/6.75 X 20
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
- No
- 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 |
|---|---|---|---|---|
| LRW | SCISSORS, GENERAL, SURGICAL | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64045 | Gynaecological scissors, single-use | A sterile hand-held manual surgical instrument designed to cut tissues during a gynaecological surgical procedure; it is not primarily intended for obstetric use. It is comprised of two pivoted shearing blades with finger and thumb ring-handles (i.e., not pinch-grip design) whereby the shearing action is directly adjacent to the handles (i.e., not alligator or endoscopic design). It is made of metal and available in a variety of blade designs; the blades may have carbide inserts along the cutting edges. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05010058188570 | GS1 | Box | 20 | In Commercial Distribution | |
| Primary | 05010058088573 | GS1 |
Customer Contacts
- Phone
- +441909735502
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 17 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry and keep out of sunlight