FDA UDI
In Commercial Distribution
🇺🇸 United States
Retractor Blade
DI: 04250337120414
·
Model: RB6583
·
Joimax GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Retractor Blade
- Primary DI
- 04250337120414
- Version / Model
- RB6583
- Catalog Number
- RB6583
- Company Name
- Joimax GmbH
- Labeler DUNS
- 344267187
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-29
- Public Version
- 1
- Public Version Date
- 2023-10-09
- Public Version Status
- New
- Public Device Record Key
- 0cef41ee-b398-4053-9708-7ad513202c92
Device Description
Retractor Blade with handle, curved Lip
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65538 | Hand-held endoscopic retractor, reusable | A hand-held manual surgical instrument intended to be used to enable retraction of tissues during endoscopic/laparoscopic surgery. It consists of a handle with a slender body connected at the distal end to a retracting mechanism (e.g., inflatable/folding paddle, fan-like spreading mechanism, retracting hook). It is intended to be introduced through a laparoscopic port or endoscopic channel; it is not intended for wound retraction or for tissue cutting. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250337120414 | GS1 |
Customer Contacts
- Phone
- +497212551407010
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | WL 90 mm / F 8.3 mm |