FDA.report

CHALLENGER TI-P

Primary DI
04046963356019
Brand
CHALLENGER TI-P
Company
Aesculap AG
Model
PL604R
Catalog number
PL604R
Device description
CHALLENGER TI-P Clip Applier Forceps, pneumatic, multi-fire, (310 mm), diam. 5 mm, consisting of PL520R, PL522R, reusable, reposable, to be used with: PL574T, PL575SU
Published
2016-09-24
Public version status
Update
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
FZPCLIP, IMPLANTABLE

Product Code Classifications

CodeDeviceSpecialtyClass
FZPClip, ImplantableGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046963356019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046963356019040469633560194046963356019

GMDN Terms

TermDefinition
Open-surgery ligation clip applierA hand-held manual surgical instrument designed to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding (i.e., haemostasis) during an open-surgery procedure. It may also be used to apply small clamps (e.g., bulldog type) to tissues however it is not intended to apply an aneurysm clip. The device is typically a metallic instrument with flat, curved ends to hold and deliver the clips (e.g., forceps-like); implantable clips are not included. This is a reusable device after sterilization.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
315018218
Device count
1
DM exempt
true
Premarket exempt
false
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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04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
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04038653038299AESCULAPDP541RDP541R2020-06-17
04038653038305AESCULAPDP542RDP542R2020-06-17
04038653177011AESCULAPOG961ROG961R2016-09-23
04038653251407AESCULAPOG960ROG960R2016-09-23
04038653044207MIASPAS MINI-ALIFFF569RFF569R2020-06-17
04038653044214MIASPAS MINI-ALIFFF571RFF571R2020-06-17
04038653044252MIASPAS MINI-ALIFFF578RFF578R2020-06-17
04038653044283MIASPAS MINI-ALIFFF586RFF586R2020-06-17
04038653117307AESCULAPNH196NH1962017-01-27
04038653117352AESCULAPNH206NH2062017-01-27
04038653118540AESCULAPNK088NK0882015-11-11
04038653118557AESCULAPNK089NK0892015-09-24
04038653118564AESCULAPNK090NK0902015-09-24

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