FDA UDI
In Commercial Distribution
🇺🇸 United States
GAP ENDO-EXO MEDULLARY SYSTEM
DI: 07540194016553
·
Model: GAP-RUL200
·
Orthopediatrics Canada ULC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GAP ENDO-EXO MEDULLARY SYSTEM
- Primary DI
- 07540194016553
- Version / Model
- GAP-RUL200
- Catalog Number
- GAP-RUL200
- Company Name
- Orthopediatrics Canada ULC
- Labeler DUNS
- 243298854
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-13
- Public Version
- 3
- Public Version Date
- 2025-05-13
- Public Version Status
- Update
- Public Device Record Key
- f75b6138-a7ca-4908-a7f1-b818547808e9
Device Description
GAP 2.0 LAG DEPTH RULER
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTJ | GAUGE, DEPTH | Orthopedic | 888.4300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44796 | Medical ruler, reusable | A small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be an independent rigid or bendable strip applied to measured surfaces or a strip incorporated into a form convenient for measuring specific devices (e.g., screws, endodontic files/rasps). It is not an implant sizer/prosthesis trial of a predetermined size, nor is it dedicated to wound measurements. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540194016553 | GS1 |
Customer Contacts
- Phone
- +1(450)688-5144 ext. 242
- [email protected]