FDA.report

Surgical Direct

Primary DI
B382SD4000070
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD40-0007
Catalog number
SD40-0007
Device description
9 inch St. Marks Lighted Deep Pelvic Retractor, Tapered Tip 2 3/16 inch x 1 3/4 inch With Lip
Published
2022-12-02
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
GADRETRACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B382SD4000070PrimaryHIBCC0

GMDN Terms

TermDefinition
Fibreoptic retractor handleA hand-held surgical instrument with an integral fibreoptic bundle intended to accept a retractor blade (not included) to: 1) enable manipulation of the blade during non-self-retaining surgical retraction of tissues; and 2) provide illumination of deep surgical sites typically during abdominal or pelvic surgical procedures. The fibreoptic bundle is attached to a separate light source, typically via a light-source cable, to produce illumination. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 (800) 519-3293info@surgicaldirect.com

Regulatory Flags

DUNS number
124367223
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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