FDA.reportPublic FDA data

Devon

Primary DI
20884527007018
Brand
Devon
Company
Cardinal Health, Inc.
Model
52000033
Catalog number
52000033
Device description
Circumcision Tray,No Straps
Published
2016-09-24
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
10884527007011PackageGS120In Commercial Distribution
20884527007018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452700701110884527007011
2088452700701820884527007018

GMDN Terms#

Term, Definition table
TermDefinition
Circumcision kit, single-useA collection of sterile devices designed to perform a circumcision procedure. It typically includes a disinfectant, circumcision clamp, scissors, and a scalpel. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter1.3Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30884527016048Devon31145942311459422018-06-29
10884521170728Kendall507250722016-09-24
10884527023240Kerlix258525852018-06-23
10884527023295Kerlix507250722018-06-30
10884521744585Kendall8608U8608U2017-09-07
10884521744608Kendall8617U8617U2017-09-07
10884521744622Kendall8618U8618U2017-09-07
20884521100432SharpSafety8608U8608U2016-09-24
20884521100463Monoject8617U8617U2016-09-24
20884521100470Monoject8618U8618U2016-09-24
40884521023100Monoject31142222311422222016-09-24
10884521020511Monoject888124713788812471372018-06-30
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24
20884527000088Argyle888472450488847245042018-06-30
00884521144227Webcol16818168182018-06-22
10884521189652Monoject1186000444T1186000444T2016-09-24
10884527007110Argyle888816305588881630552016-09-24
20885380173537Curity7267G7267G2019-11-14
20885380173568Curity9024G9024G2019-11-14

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
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