FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10889942321148
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYND04178
Catalog number
DYND04178
Device description
CLAMP CIRCUM 1.45CM STR
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
40889942321149PackageGS110In Commercial Distribution
10889942321148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088994232114940889942321149
1088994232114810889942321148

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA general-purpose collection of various sterile surgical instruments, dressings, and materials intended to be used to assist a range of surgical procedures across multiple clinical specialities. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320493MEDLINEMDS30201MDS302012026-09-04
10080196320516MEDLINEMDS30203MDS302032026-09-05
10197344039418HUDSON RCIHUD99001KITHUD99001KIT2026-09-04
10197344043064HUDSON RCIHUD99060KITHUD99060KIT2026-09-04
10197344043071HUDSON RCIHUD99060HUD990602026-09-04
10197344043101HUDSON RCIHUD99018KITHUD99018KIT2026-09-04
10197344043118HUDSON RCIHUD99009KITHUD99009KIT2026-09-04
10197344148332MEDLINERTDCIDDHNRTDCIDDHN2026-09-04
10197344148707MEDLINERTDCIVOMRRTDCIVOMR2026-09-04
10197344204540MEDLINEMDSDAMPLGMDSDAMPLG2026-09-04
10197344204557MEDLINEMDSDAMPMGMDSDAMPMG2026-09-04
10197344204564MEDLINEMDSDAMPXLGMDSDAMPXLG2026-09-04
10888277415010MEDLINEAEG001SAEG001S2026-09-04
10888277415027MEDLINEAEG017SAEG017S2026-09-04
10080196304752MEDLINEDYNJP2203SDYNJP2203S2016-10-14
10080196714100MEDLINEDYNJP2003DYNJP20032016-10-14
10080196894536MEDLINEDYNJP6010DYNJP60102021-01-26
10884389106280MEDLINEDYND70279DYND702792023-01-27
20888277699561MEDLINENONLV340NONLV3402020-12-04
10884389393697Medline Industries, Inc.DYNJASM1DYNJASM12019-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489086331MEDLINEMEDLINE INDUSTRIES, INC.HFX2026-08-27
10197344003075MEDLINEMEDLINE INDUSTRIES, INC.HFX2026-01-12
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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
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16939550822347ShangRingWuhu Snnda Medical Treatment Appliance Technology Co., Ltd.HFX2021-03-19
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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