FDA.report

MT

Primary DI
56932503549375
Brand
MT
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
BF10001
Device description
"Cam Structure,Alligator forceps. PTFE coating. 1.0*1200mm "
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FCLForceps, Biopsy, Non-Electric

Product Code Classifications

CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
56932503549375PackageGS12In Commercial Distribution
66932503549372PackageGS125In Commercial Distribution
06932503549370PrimaryGS10
46932503549378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
5693250354937556932503549375
6693250354937266932503549372
06932503549370069325035493706932503549370
4693250354937846932503549378

GMDN Terms

TermDefinition
Flexible endoscopic biopsy forceps, single-useA flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.

Device Sizes

TypeValueUnit
Length1200Millimeter
Outer Diameter1Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
877-552-4027info@micro-tech-usa.com

Regulatory Flags

DUNS number
530269083
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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