FDA UDI
In Commercial Distribution
🇺🇸 United States
Guardian VAGINAL RETRACTOR™
DI: 00888937013184
·
Model: 64-330
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Guardian VAGINAL RETRACTOR™
- Primary DI
- 00888937013184
- Version / Model
- 64-330
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-26
- Public Version
- 3
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 829529e0-092f-401a-90e8-0d0ad2e59125
Device Description
Guardian VAGINAL RETRACTOR™ Use for Vaginal Inspection and Repair of Episiotomy and Vaginal Laceration
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| KOH | Instrument, Manual, General Obstetric-Gynecologic | Obstetrics/Gynecology | 884.4520 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47991 | Self-retaining surgical retractor, single-use | A sterile, hand-operated, self-retaining, one-piece 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 intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888937013184 | GS1 | ||||
| Package | 20888937013188 | GS1 | 6 | In Commercial Distribution |