MERIGLUETM – Topical Skin Adhesive
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Basic Information
- Brand Name
- MERIGLUETM – Topical Skin Adhesive
- Primary DI
- 08904255228665
- Version / Model
- BCA-0.5
- Company Name
- MERIL ENDO SURGERY PRIVATE LIMITED
- Labeler DUNS
- 870914838
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2026-04-18
- Public Version
- 1
- Public Version Date
- 2026-04-27
- Public Version Status
- New
- Public Device Record Key
- dc1909b6-c295-4352-886c-eb6178245bad
Device Description
The MeriGlu™ is a sterile, liquid topical skin tissue adhesive containing a monomer (N-Butyl Cyanoacrylate(97 %), Plasticizer – Acetyl Tri-Butyl Citrate (2.8 %) and the Colorant D & C Violet No. 2 (0.2 %). It is provided in a sealed aluminium tube with a loosely attached single use nozzle. Both aluminum tube and nozzles are individually packed in PET tray with Tyvek lid. The nozzles are composed of a selfpuncturing closure and a soft tip which provides uniform spreading of adhesive on application site. As applied to skin tissues, the liquid adhesive polymerizes within minutes.
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 Safe
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | General, Plastic Surgery | 878.4010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34164 | Skin-approximation adhesive | A sterile biodegradable glue made of synthetic polymer (e.g., cyanoacrylate) intended for topical closure of surgical incisions and simple traumatic lacerations that have easily-approximated skin edges; it is not intended for internal surgical applications. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 18904255228662 | GS1 | ||||
| Primary | 08904255228665 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230981 | 000 |