FDA.reportPublic FDA data

Medline

Primary DI
10080196301898
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS10780
Catalog number
MDS10780
Device description
CLAMP,CIRCUMCISION,1.1CM,NONSTERILE
Published
2016-10-14
Public version status
Update
Distribution status
Not 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
10080196301898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1008019630189810080196301898

GMDN Terms#

Term, Definition table
TermDefinition
Surgical penis clamp, single-useA sterile, hand-held manual surgical instrument designed to grasp the penis for manipulation during surgery (e.g., circumcision). It is typically a clip-like device e.g., with self-retaining levers. The penis is placed into this clamp that closes around or on the organ. This is a single-use device.

Sterilization Methods#

Method table
Method

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
10888277419452MEDLINEMDTZ1068516ABMDTZ1068516AB2016-10-14
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11

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