FDA.reportPublic FDA data

Medline

Primary DI
10080196301904
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS10781
Catalog number
MDS10781
Device description
CLAMP,CIRCUMCISION,1.3CM,NONSTERILE
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HFXCLAMP, CIRCUMCISION

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040052000FINE SURGICAL CIRCUMCISION CLAMPFine Surgical Instrument Corp.2004-04-09HFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10080196301904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1008019630190410080196301904

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196415397MEDLINEMSC97412MSC974122026-05-27
10653160393634MEDLINEDYNDV2733ADYNDV2733A2026-05-27
10653160393665MEDLINEDYNDV2772DYNDV27722026-05-27
10653160393689MEDLINEDYNDV2787DYNDV27872026-05-27
10653160393702MEDLINEDYNDV2783DYNDV27832026-05-27
10653160393719MEDLINEDYNDV2797DYNDV27972026-05-27
10653160393726MEDLINEDYNDC2483ADYNDC2483A2026-05-27
10653160393733MEDLINEDT22665ADT22665A2026-05-27
10888277415386MEDLINEMSC97410MSC974102026-05-27
10888277415393MEDLINEMSC9748MSC97482026-05-27
10888277677289MEDLINEMSC97414MSC974142026-05-27
10888277677296MEDLINEMSC9746MSC97462026-05-27
10888277177680MEDLINEMDSMR117MDSMR1172021-05-14
10884389120620MEDLINEMDSMR112MDSMR1122021-04-23
10884389120675MEDLINEMDSMPHS2MDSMPHS22021-04-23
10884389128756MEDLINEMDSMR113MDSMR1132021-04-23
10884389177679MEDLINEMDSMPHS1MDSMPHS12021-04-23
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29

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