FDA.report

Stealth Surgical

Primary DI
00888515257573
Brand
Stealth Surgical
Company
BOSS INSTRUMENTS, LTD., INC.
Model
SS1022
Catalog number
SS1022
Device description
STEALTH ACF BLADE SHORT TEETH 40MM RED
Published
2016-10-01
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
GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888515257573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515257573008885152575738885152575730888515257573

GMDN Terms

TermDefinition
Laminectomy retractor, self-retainingA self-locking, surgical instrument, used for separating the edges or drawing aside the margins of a surgical incision to permit excision of the lamina of the vertebral posterior arch; this can be necessary to expose a portion of the spinal cord for removal of a tumour, relief of pressure due to a fracture, or disc protrusion. The instrument may resemble a large pair of scissors with wide-angle blades which have fenestrated curved hooks, often terminating in sharp points, at the distal end to grasp the tissues. It is usually made of stainless steel and comes in a variety of designs. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(540)832-5580info@stealthsurgical.com
+1(540)832-5000orders@bossinstruments.com

Regulatory Flags

DUNS number
848522678
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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