FDA UDI
In Commercial Distribution
🇺🇸 United States
ORLocate
DI: 10724995220119
·
Model: ORLocate Gauze
·
STERIS CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
4
Pkg Device Count
10
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Basic Information
- Brand Name
- ORLocate
- Primary DI
- 10724995220119
- Version / Model
- ORLocate Gauze
- Catalog Number
- GTS0804X1610
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 036985604
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-03-14
- Public Version
- 2
- Public Version Date
- 2025-04-24
- Public Version Status
- Update
- Public Device Record Key
- ef76f434-7141-4c5f-9ed3-843061584d8c
Device Description
ORLocate RFID Gauze 16-ply is used with the ORLocate Sponge Solution System.
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAB | Gauze / sponge,nonresorbable for external use | General, Plastic Surgery | 878.4014 | 1 |
| GDY | Gauze/sponge, internal, x-ray detectable | General, Plastic Surgery | 878.4450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38496 | Radiopaque woven surgical sponge | A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50724995220117 | GS1 | Case | 80 | In Commercial Distribution | |
| Primary | 10724995220119 | GS1 | ||||
| Unit of Use | 00724995220112 | GS1 | ||||
| Previous | 15060356150400 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]