FDA.report

V. Mueller

Primary DI
10885403070495
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
NL850-2050
Catalog number
NL850-2050
Device description
PERITONEAL SHUNT PASSER NON-STERILE
Published
2020-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GYKInstrument, shunt system implantation

Product Code Classifications

CodeDeviceSpecialtyClass
GYKInstrument, Shunt System ImplantationNeurology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885403070495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088540307049510885403070495

GMDN Terms

TermDefinition
Wire/ligature passer, reusableA hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)323-9088Customer_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
true

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50885403184473NA446844682018-07-18
50885403184480NA4469A4469A2018-07-18
50885403192829Scrub Care ExidineCLEAN1CLEAN12018-05-02
10885403465154Snowden-PencerSI325SI3252018-01-16

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
03760124131444SophysaSOPHYSAGYK2023-06-02
13760124131458SophysaSOPHYSAGYK2023-06-02
03760124131468SophysaSOPHYSAGYK2023-06-02
03760124131475SophysaSOPHYSAGYK2023-06-02
04041906507336AESCULAPAesculap AGGYK2023-04-03
04041906507343AESCULAPAesculap AGGYK2023-04-03
04041906507350AESCULAPAesculap AGGYK2023-04-03
04041906507367AESCULAPAesculap AGGYK2023-04-03
04041906507374AESCULAPAesculap AGGYK2023-04-03
04041906507381AESCULAPAesculap AGGYK2023-04-03
04041906507398AESCULAPAesculap AGGYK2023-04-03
04041906507404AESCULAPAesculap AGGYK2023-04-03
00763000031268N/AMEDTRONIC PS MEDICAL, INC.GYK2020-07-20
00382830058193Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-17
00382830058186Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-17
10885403070488V. MuellerCAREFUSION 2200, INCGYK2020-04-15
10885403070501V. MuellerCAREFUSION 2200, INCGYK2020-04-15
00382830057370Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-03
00382830057363Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-03
00382830057509Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-03
00382830057431Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-03
00382830055420Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-03
10381780515487CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2020-04-01
10381780515494CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2020-04-01
10381780515500CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2020-04-01
00381780521399CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2020-04-01
00381780521405CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2020-04-01
00381780521412CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2020-04-01
00763000260019N/AMEDTRONIC PS MEDICAL, INC.GYK2020-03-26
00763000260026N/AMEDTRONIC PS MEDICAL, INC.GYK2020-03-26