FDA.report

E-LINE

Primary DI
04055207018583
Brand
E-LINE
Company
Richard Wolf GmbH
Model
8652788
Catalog number
8652.788
Device description
INSTRUMENT PORT 4FR TL 31 mm, capacity for instruments up to 4 Fr, compatible with working element 8652.781, with introduction port, reusable
Published
2024-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207018583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207018583040552070185834055207018583

GMDN Terms

TermDefinition
Pin-indexed adaptor, reusableA connecting device intended to join two incompatible devices/components through a system of uniquely coded pins, slots, or holes which match when united, and provide security against the inadvertent coupling of devices other than a specific pair. The device is often used to connect an anaesthetic agent container to its dedicated vapourizer. This is a reusable device.

Device Sizes

TypeValueUnit
Outer Diameter1.33333333333Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
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
true
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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