FDA.reportPublic FDA data

GoldenDent

Primary DI
00850028211892
Brand
GoldenDent
Company
GoldenDent
Model
SPGA4
Catalog number
SPGA4
Device description
Coated Polyglycolic Acid (PGA) Braided Absorbable Suture Violet, 4-0, 19mm, 3/8 reverse cutting needle, Qty 12
Published
2021-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073614000WG-SURGICAL SUTURES WITH NEEDLEFoosin Medical Supplies, Inc.2008-04-30NEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850028211472PrimaryGS10
00850028211892Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850028211472008500282114728500282114720850028211472
00850028211892008500282118928500282118920850028211892

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, single-useA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078273228
Device count
12
DM exempt
false
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850028211335WagotrixWGWL-100WGWL-1002021-02-25
00850028211342WagotrixWGWM-100WGWM-1002021-02-25
00850028211359WagotrixWGWS-100WGWS-1002021-02-25
00850011211625GoldenDentGMXRGMXR2021-02-25
00850011211939GoldenDentGO AGKGO AGK2021-02-26
00850011211830GoldenDentGO CGCGO CGC2021-02-25
00850011211946GoldenDentGO GKIGO GKI2021-02-26
00850011211823GoldenDentGO BFIGO BFI2021-02-25
00850011211915GoldenDentGO SPCGO SPC2021-02-25
00850011211403GoldenDentGK06GK062021-02-25
00850011211410GoldenDentGK08GK082021-02-25
00850011211427GoldenDentGK10GK102021-02-25
00850011211434GoldenDentGK15GK152021-02-25
00850011211441GoldenDentGK20GK202021-02-25
00850011211458GoldenDentGK25GK252021-02-25
00850011211465GoldenDentGK30GK302021-02-25
00850011211472GoldenDentGK35GK352021-02-25
00850011211489GoldenDentGK40GK402021-02-25
00850011211496GoldenDentGK45GK452021-02-25
00850011211502GoldenDentGK50GK502021-02-25

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