FDA.reportPublic FDA data

Gomco Type Circumcision Clamp

Primary DI
00869401000220
Brand
Gomco Type Circumcision Clamp
Company
FINE SURGICAL INSTRUMENTS INC.
Model
28-856
Catalog number
28-856
Device description
Gomco Type Circumcision Clamp Disposable Chrome Plated , Infant 1.45cm
Published
2016-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HFXCLAMP, CIRCUMCISION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFXClamp, CircumcisionObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869401000220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869401000220008694010002208694010002200869401000220

GMDN Terms#

Term, Definition table
TermDefinition
Circumcision clamp, single-useA sterile, hand-held manual surgical instrument designed for the controlled removal of the foreskin of the penis during circumcision. It is typically made of metal and/or plastic materials and can have various designs, e.g., the Bell clamp. The foreskin is pushed over the bell-shaped protection rod and the glans placed into it. A screw mechanism is tightened so that the foreskin is annular compressed and is cut-off using, e.g., a scalpel, following the compression ring. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(516)292-7400mirza@finesurgical.com

Regulatory Flags#

DUNS number
103669727
Device count
1
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869401000206Gomco Type Circumcision Clamp28-85428-8542016-10-10
00869401000213Gomco Type Circumcision Clamp28-85528-8552016-10-10
00869401000237Gomco Type Circumcision Clamp28-85728-8572016-10-10
00869401000244Gomco Type Circumcision Clamp903-014903-0142016-10-10
00869401000251Gomco Type Circumcision Clamp903-016903-0162016-10-10
00869401000268Gomco Type Circumcision Clamp903-018903-0182016-10-10
00869401000275Gomco Type Circumcision Clamp903-020903-0202016-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344003075MEDLINEMEDLINE INDUSTRIES, INC.HFX2026-01-12
16939550822118ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822125ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822132ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822149ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822156ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822163ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822187ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822200ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822224ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822248ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822262ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822286ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822293ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822309ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822316ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822323ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822330ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822347ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822354ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822361ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822378ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822385ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822392ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
16939550822408ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
26939550822115ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
26939550822122ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
26939550822139ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
26939550822146ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
26939550822153ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19