FDA.reportPublic FDA data

ENDO-SCRUB™ 2

Primary DI
00763000548742
Brand
ENDO-SCRUB™ 2
Company
MEDTRONIC XOMED, INC.
Model
1991015
Device description
FINGER SWITCH 1991015 ENDO-SCRUB 2 ROHS
Published
2025-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EOBNasopharyngoscope (flexible or rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982594000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982594000ENDO-SCRUB/ENDO-SCRUB 2Xomed, Inc.1998-08-27EOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000548742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000548742007630005487427630005487420763000548742

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope lens cleaner, gas/fluid, reusableA device intended to be used for the in situ removal of blood/debris from the lens of an endoscope, or other endoscopic device, by directing gas or liquid to the edge of the lens. It is a tubular device, made from metal or plastic, intended to be attached to the inserted portion of the endoscopic device whereby gases/fluids are directed from a source (e.g., manual pump, drop infusion pack) to the lens. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000843908NIM VitalNIM4CM012026-08-22
00763000843915NIM VitalNIM4CPB12026-08-22
00199150037407NIM™8225825X2026-03-29
00643169644656Otomag™ Attract™ Magnetic SpacerS0266-002016-04-15
00643169644663Otomag™ Attract™ Magnetic SpacerS0266-012016-04-15
00643169644670Otomag™ Attract™ Magnetic SpacerS0266-022016-04-15
00643169644687Otomag™ Attract™ Magnetic SpacerS0266-032016-04-15
00643169644694Otomag™ Attract™ Magnetic SpacerS0266-042016-04-15
00643169644700Otomag™ Attract™ Magnetic SpacerS0266-052016-04-15
00643169644717Otomag™ Attract™ Magnetic SpacerS0266-062016-04-15
00643169644731Otomag™ Attract™ Magnetic SpacerS0266-082016-04-15
00643169644748Otomag™ Attract™ Magnetic SpacerS0266-092016-04-15
00643169644755Otomag™ Attract™ Magnetic SpacerS0266-102016-04-15
00643169644762Otomag™ Attract™ Magnetic SpacerS0266-112016-04-15
00643169644779Otomag™ Attract™ Magnetic SpacerS0266-152016-04-15
00643169644786Otomag™ Attract™ Magnetic SpacerS0266-212016-04-15
00643169644793Otomag™ Attract™ Magnetic SpacerS0542-002016-04-15
00643169644809Otomag™ Attract™ Magnetic SpacerS0542-012016-04-15
00643169644816Otomag™ Attract™ Magnetic SpacerS0542-022016-04-15
00643169644823Otomag™ Attract™ Magnetic SpacerS0542-032016-04-15

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