AnchorEntry Retractor, Double Flange, 70 mm

FDA UDI

Class II (US FDA UDI)

by Baylis Médicale Cie Inc

Identity

Trade Name: AnchorEntry Retractor, Double Flange, 70 mm FDA UDI
Generic Name: Hand-held surgical retractor, reusable FDA UDI
Model / Reference: PSZ-200-206 FDA UDI

Identifiers

Primary DI / UDI-DI: 00685447001836 FDA UDI
FDA Product Code: HRX FDA UDI
GMDN Term: Hand-held surgical retractor, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

AnchorEntry Retractor, Double Flange, 70 mm by Baylis Médicale Cie Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Baylis Médicale Cie Inc

Sources (1)

FDA UDI 26a5aa0b-e566-4764-837b-224afb50e494 34 fields · synced Jun 8, 2026