FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterling Medical Products
DI: 00685404003125
·
Model: TMS-18-370-16-STRL
·
APOLLO MEDICAL PRODUCTS CORP.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Sterling Medical Products
- Primary DI
- 00685404003125
- Version / Model
- TMS-18-370-16-STRL
- Company Name
- APOLLO MEDICAL PRODUCTS CORP.
- Labeler DUNS
- 116768422
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-14
- Public Version
- 1
- Public Version Date
- 2024-05-22
- Public Version Status
- New
- Public Device Record Key
- 0f34ec10-d337-4c51-80f1-56dc1635e452
Device Description
WEITLANER RETRACTOR 7"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62562 | Hand-held surgical retractor, single-use | A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10685404003122 | GS1 | CARTON | 50 | In Commercial Distribution | |
| Primary | 00685404003125 | GS1 |
Customer Contacts
- Phone
- 8155375303
- [email protected]