FDA.report

Burkhart 4-0 PolyGlycolic Acid Suture, Undyde, BRD, 18" (12)

Primary DI
00815878020728
Brand
Burkhart 4-0 PolyGlycolic Acid Suture, Undyde, BRD, 18" (12)
Company
BURKHART DENTAL SUPPLY CO., THE
Model
72720833
Published
2017-10-27
Public version status
Update
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
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Product Code Classifications

CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815878020728PrimaryGS10
00815878020735Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815878020728008158780207288158780207280815878020728
00815878020735008158780207358158780207350815878020735

GMDN Terms

TermDefinition
Polyglycolic acid sutureA sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. It may include an attached needle intended to be disposed of after single use; it may be coated with a material such as polycaprolactone or uncoated. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
(800) 562-8176customerservice@burkhartdental.com

Regulatory Flags

DUNS number
027532357
Device count
12
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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