FDA UDI
In Commercial Distribution
🇺🇸 United States
Instrapac
DI: 05010058087743
·
Model: 8774 Delivery Pack with Drape and Large XRD swabs
·
ROBINSON HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Instrapac
- Primary DI
- 05010058087743
- Version / Model
- 8774 Delivery Pack with Drape and Large XRD swabs
- Catalog Number
- 8774
- Company Name
- ROBINSON HEALTHCARE LIMITED
- Labeler DUNS
- 237799775
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-26
- Public Version
- 3
- Public Version Date
- 2022-07-18
- Public Version Status
- Update
- Public Device Record Key
- a1ba69b7-4f08-49d4-91f0-a1e40cab0850
Device Description
Instrapac Delivery Pack with Drape and Large XRD swabs. 20 packs per Case. Contents: 1 x Umbilical Cord Scissors 10cm/4in, 1 x Mayo Scissors Curved 17cm/6.75in, 2 x Spencer Wells Forceps Straight 18cm/7in, 2 x Umbilical Cord Clamps, 5 x Large XRD Swabs 30cm x 30cm (12in x 12in), 1 x Drape 90cm x 90cm (35in x 35in). Provided in a crepe paper wrap.
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
- No
- 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 |
|---|---|---|---|---|
| MLS | Labor And Delivery Kit | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34988 | Birthing/delivery kit | A collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn. It contains the necessary instruments, dressings, and pharmaceuticals necessary for this procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05010058187740 | GS1 | Case = 20 packs | 20 | In Commercial Distribution | |
| Primary | 05010058087743 | GS1 |
Customer Contacts
- Phone
- 858 4871859
- [email protected]