FDA.reportPublic FDA data

ApollOS

Primary DI
00844505014403
Brand
ApollOS
Company
Grace Medical, Inc.
Model
800
Device description
ApollOS™
Published
2024-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10844505014400PackageGS110In Commercial Distribution
00844505014403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084450501440010844505014400
00844505014403008445050144038445050144030844505014403

GMDN Terms#

Term, Definition table
TermDefinition
Mouthguard, single-useA prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during surgery or intubation. It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
030849173
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844505014625HOUGH FLAP KNIFE999-2042026-03-27
00844505014632THOMASSIN DISSECTOR999-2052026-03-27
00844505010269TITANIUM/FLUOROPLASTIC PISTON409-6002026-02-03
00844505014526GRACE PISTON412-5252026-01-07
00844505014533GRACE PISTON412-5502026-01-07
00844505014540GRACE PISTON412-5752026-01-07
00844505012249EndoEar™ ENDOSCOPE, 3MM X 150MM, 0 DEG.EE-03002019-12-05
00844505012256EndoEar™ ENDOSCOPE, 3MM X 150MM, 30 DEG.EE-03302019-12-05
00844505012263EndoEar™ ENDOSCOPE, 3MM X 150MM, 45 DEG.EE-03452019-12-05
00844505012270EndoEar™ ENDOSCOPE, 3MM X 150MM, 70 DEG.EE-03702019-12-05
00844505014694SKULL BASE999-SB12025-09-26
00844505014700SKULL BASE999-SB22025-09-26
00844505014717SKULL BASE999-SB52025-09-26
00844505014724SKULL BASE999-SB62025-09-26
00844505014502TITANIUM PISTON461-5752025-09-18
00844505014687GRACE MEDICAL FLUOROPLASTIC PISTON402-5502025-09-18
00844505014489ECLIPSE PISTON467-3502025-08-05
00844505014519TITANIUM PISTON460-5752025-08-05
00844505014564GRACE MEDICAL FLUOROPLASTIC PISTON402-4752025-08-05
00844505014670GRACE MEDICAL FLUOROPLASTIC PISTON402-5752025-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091896ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506091902ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506091971ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506093623ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
04059453127471Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-07-16
04059453133809Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-07-16
04250407786571FENTEXFENTEX medical GmbHLRC2024-08-01
04250407785765FENTEXFENTEX medical GmbHLRC2022-12-15
04250407785772FENTEXFENTEX medical GmbHLRC2022-12-15
04250407785789FENTEXFENTEX medical GmbHLRC2022-12-15
04250407736866FENTEXFENTEX medical GmbHLRC2022-12-12
04250407736873FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737252FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737443FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737559FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737573FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737597FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737610FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737771FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737788FENTEXFENTEX medical GmbHLRC2022-12-12
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04250407738051FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738082FENTEXFENTEX medical GmbHLRC2022-12-12
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04250407738105FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738112FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738174FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738242FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738259FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738266FENTEXFENTEX medical GmbHLRC2022-12-12