FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE
DI: 30197344074369
·
Model: MLABINLOOP10F
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1000
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Basic Information
- Brand Name
- MEDLINE
- Primary DI
- 30197344074369
- Version / Model
- MLABINLOOP10F
- Catalog Number
- MLABINLOOP10F
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2025-11-14
- Public Version
- 1
- Public Version Date
- 2025-11-24
- Public Version Status
- New
- Public Device Record Key
- b99a7e73-8b93-4339-87d8-2b4263300a02
Device Description
INOCULATIONLOOP,10UL,ST,FLEXIBLE,6000/CS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| LIB | DEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61712 | Microbial specimen inoculation/streaking/colony-picking instrument IVD | An electrically-powered instrument intended for the pre-analytical preparation of microbial samples (e.g., cultures, suspensions, MALDI-TOF targets/slides) from a clinical specimen and/or culture isolate. Its functionality includes: 1) automated/semi-automated transfer of the clinical specimen (e.g., by aspiration or inoculating loop), inoculation into/onto culture dishes/tubes/slides, and streaking of culture dishes (e.g., using magnetic beads, inoculation loops or spreaders); and/or 2) automated microbial colony picking for the preparation of samples for subsequent analytical procedures. It may also feature processing capabilities such as barcoding, storage, and/or sorting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20197344074362 | GS1 | CS | 6 | In Commercial Distribution | |
| Primary | 30197344074369 | GS1 | ||||
| Unit of Use | 10197344074365 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]