FDA.reportPublic FDA data

N/A

Primary DI
50885403473171
Brand
N/A
Company
CAREFUSION 2200, INC
Model
5513E
Catalog number
5513E
Device description
Surgical Clipper
Published
2019-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWKRAZOR, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWKRazor, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885403473170PackageGS11In Commercial Distribution
50885403473171PackageGS120In Commercial Distribution
10885403473173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088540347317020885403473170
5088540347317150885403473171
1088540347317310885403473173

GMDN Terms#

Term, Definition table
TermDefinition
Surgical hair clippersA hand-held electrically-powered device designed for removing long hair from the head or body of a patient prior to surgery/treatment. The device is typically operated by a healthcare professional. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid stacking Items vertically, maximum number of items is 10
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-0502Customer_Support@BD.com

Regulatory Flags#

DUNS number
832696038
Device count
1
DM exempt
false
Premarket exempt
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403075995Denver42-200042-20002017-06-12
10885403076008Denver42-205542-20552017-06-12
10885403242342AchieveM1411M14112017-06-12
10885403242359AchieveM1415M14152017-06-12
10885403242366AchieveM1811M18112017-06-12
10885403242373AchieveM1815M18152017-06-12
10885403057229JamshidiBAK4508BAK45082016-09-23
10885403057236JamshidiBAK4511BAK45112016-09-23
10885403057267JamshidiBEK4511BEK45112016-09-30
10885403075971PleurX50-7000B50-7000B2017-09-15
10885403076022Denver42-301942-30192017-06-12
10885403076046Denver42-900042-90002017-06-12
10885403107702JamshidiBCTM3411SPBCTM3411SP2016-09-30
10885403108365Safe-T-CentesisPIG1260TPIG1260T2018-07-18
10885403108389Safe-T-CentesisPIG1260TSPPIG1260TSP2018-07-18
10885403108402Safe-T-CentesisPIG1280TPIG1280T2018-07-18
10885403108426Safe-T-CentesisPIG1280TSPPIG1280TSP2018-07-18
10885403108433Safe-TTPT1000SPTPT1000SP2018-07-18
10885403108488NATPT1000TPT10002018-07-18
10885403108495Safe-TTPT1000SDFTPT1000SDF2018-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885380213281CARDINAL HEALTHCardinal Health 200, LLCLWK2026-05-27
00197998192449Solventum™Solventum US LLCLWK2026-02-15
00197998192463Solventum™Solventum US LLCLWK2026-02-15
00197998192487Solventum™Solventum US LLCLWK2026-02-15
00197998192715Solventum™Solventum US LLCLWK2026-02-15
00197998192739Solventum™Solventum US LLCLWK2026-02-15
00197998192753Solventum™Solventum US LLCLWK2026-02-15
00197998276347Solventum™Solventum US LLCLWK2026-02-15
00197998315503Solventum™Solventum US LLCLWK2026-02-15
00197998315534Solventum™Solventum US LLCLWK2026-02-15
00197998192456Solventum™Solventum US LLCLWK2026-02-15
00197998192470Solventum™Solventum US LLCLWK2026-02-15
00197998192494Solventum™Solventum US LLCLWK2026-02-15
00197998192722Solventum™Solventum US LLCLWK2026-02-15
00197998192746Solventum™Solventum US LLCLWK2026-02-15
00197998192760Solventum™Solventum US LLCLWK2026-02-15
00197998276354Solventum™Solventum US LLCLWK2026-02-15
00197998315510Solventum™Solventum US LLCLWK2026-02-15
00197998315541Solventum™Solventum US LLCLWK2026-02-15
00661392011755LSL HEALTHCARELSL Industries, LLCLWK2025-10-30
107073878145783M™3M COMPANYLWK2025-03-28
507073878145763M™3M COMPANYLWK2025-03-28
00850063139328NEIL MEDICALNeil Medical GroupLWK2025-03-14
85006313932800NEIL MEDICALNeil Medical GroupLWK2025-03-14
107073878145853M™3M COMPANYLWK2024-08-19
107073878145923M™3M COMPANYLWK2024-08-19
107073878146083M™3M COMPANYLWK2024-08-19
107073878146153M™3M COMPANYLWK2024-08-19
507073878145833M™3M COMPANYLWK2024-08-19
507073878145903M™3M COMPANYLWK2024-08-19